SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang, Djamila Batache and Christine Schweikard, Bär & Karrer AG
2. Clinical Trials 2.1 Regulation of Clinical Trials
• category A – medicinal products that may be dispensed on a one-time basis on a physi- cian’s prescription (Article 41 of the OMP); • category B – medicinal products that require a prescription and can be obtained several times, whereby medicinal products on list B+ can also be dispensed without a prescription (Article 42 of the OMP); • category D – medicinal products that may be dispensed without a prescription, but after specialist advice (Article 43 of the OMP); and • category E – medicinal products that may be dispensed without a prescription and without specialist advice (Article 44 of the OMP). The assignment to a particular category deter- mines who is authorised to dispense, prescribe and use the medicinal product (Articles 24 et seq of the TPA). Non-prescription medicinal prod- ucts, known as OTC medicinal products, are intended for self-medication. The classification into the different categories is made by Swiss- medic (Article 23a of the TPA). The TPA further contains special provisions for blood and blood products (Articles 34 et seq of the TPA) as well as for veterinary medicinal prod- ucts (Articles 42 et seq of the TPA). Medical devices are divided into different cat- egories (classes I, IIa, IIb, III) – for which, different conformity assessment procedures apply. The classification follows the respective regulation in the EU-MDR (Article 16 paragraph 1 of the MedDO) and is based on the intended purpose and the associated risk. Certain medical devices may be classified as intended for use by health- care professionals (HCPs) only.
Clinical trials are mainly governed by the TPA, the Human Research Act (HRA), the Human Research Ordinance (HRO), the Clinical Trials Ordinance ( “ClinO” ) and the Ordinance on Clini- cal Trials with Medical Devices ( “ClinO-MD” ). In principle, clinical trials with therapeutic prod- ucts require prior authorisation from Swiss- medic (Article 54 paragraph 1 of the TPA) and the competent ethics committee (Articles 24 et seq of the ClinO and Articles 9 et seq of the Cli- nO-MD). Regarding medicinal products, Swiss- medic examines whether the good manufac- turing practice (GMP) and safety requirements are met (Article 54 paragraph 4 lit a of the TPA). Regarding medical devices, the assessment includes the conformity of the products with the safety requirements (Article 54 paragraph 4 lit b of the TPA and Article 45 paragraphs 1 and 3 of the TPA). Clinical trials must be conducted in line with the rules of good clinical practice as set out, with regard to medicinal products, in the International Council for Harmonisation (ICH) Guideline on Good Clinical Practice of 9 November 2016 and the World Medical Association (WMA) Declara- tion of Helsinki on Ethical Principles for Medical Research Involving Human Subjects (Article 5 paragraph 1 of the ClinO and Article 3 of the ClinO-MD). With regard to medical devices, the applicable rules on good clinical practice were incorporated into Swiss legislation by way of reference to Article 72 and Annex XV Chapters I and III of the EU-MDR, as well as in EN ISO 14155.
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